Hydrocortisone

Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 80693, held by Fougera Pharms Inc. Hydrocortisone.

As of Nov 13, 2026, ANDA 80693 (Hydrocortisone), held by Fougera Pharms Inc, was first approved by FDA on Apr 30, 1976, with 8 approved supplements and 0 published complete response letters.

First approved: Apr 30, 1976
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Apr 30, 1976	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrocortisone1% · cream;topical	Hydrocortisone	RxReference drug

All 9 submissions, including labeling and manufacturing supplements


Jun 10, 1996	Supplement 50Manufacturing	Approved	None posted
Mar 7, 1996	Supplement 51Manufacturing	Approved	None posted
Jul 30, 1987	Supplement 48Manufacturing	Approved	None posted
Feb 10, 1986	Supplement 44Manufacturing	Approved	None posted
Feb 10, 1986	Supplement 45Manufacturing	Approved	None posted
Feb 10, 1986	Supplement 46Manufacturing	Approved	None posted
Jan 26, 1984	Supplement 43Manufacturing	Approved	None posted
May 11, 1982	Supplement 39Manufacturing	Approved	None posted
Apr 30, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 80693
Drugs@FDA: Overview at FDA
Company: Fougera Pharmaceuticals Inc.

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters